NCT02536482

Brief Summary

It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

August 20, 2015

Last Update Submit

August 28, 2015

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Study to assess the allergic symptoms, using a questionnaire.

    The allergic symptoms were assessed every month, by using a questionnaire. The parents, during the medical appointment, answered "yes" or "no" according to the presented symptoms: cutaneous (atopic dermatitis and urticaria), gastrointestinal (vomiting, diarrhea constipation and bloody stools ) and respiratory. At the end of the study the children were evaluated if they tolerated the formula, it was observed by the symptoms remission.

    5 months

Secondary Outcomes (3)

  • Weight assessment, using a digital infant scale

    5 months

  • Height assessment, using an infantometer

    5 months

  • Head circumference, using an infant tape measure

    5 months

Study Arms (1)

Amix

EXPERIMENTAL

Dietary supplement. The formula is based in free amino-acid to treat children with cow's milk allergy. The children should have a minimum consumption of 400 mL, daily.

Dietary Supplement: Amix

Interventions

AmixDIETARY_SUPPLEMENT

Treat the children with cow's milk allergy for 5 months.

Amix

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with cow's milk allergy

You may not qualify if:

  • Children without cow's milk allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Wendel O Afonso, Master

    UFMG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 31, 2015

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

August 31, 2015

Record last verified: 2015-08